Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

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XTalks

MARCH 28, 2024

Causes and Risk Factors for Endometriosis As the exact cause of endometriosis remains unclear, many potential causes are being proposed, including retrograde menstruation (where menstrual blood flows back into the pelvic cavity instead of leaving the body), immune system disorders and hormonal imbalances.

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Pfizer

JANUARY 27, 2023

The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision. This opinion from the CHMP confirms that the benefits of PAXLOVID in helping to reduce severe COVID-19-related outcomes, including hospitalization and death, in high risk patients continue to outweigh its potential risks.

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XTalks

NOVEMBER 19, 2021

Natriuretic peptides like N-terminal (NT)-pro hormone B type natriuretic peptide (NT-proBNP), or BNP, are routinely used for acute and chronic heart failure. While cardiac biomarkers hold promise as relatively non-invasive biological indicators of cardiac disease, drug response and prognosis, Dr. Lee says they can be a double-edged sword.

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The Pharma Data

DECEMBER 9, 2020

Our focus on partnering to accelerate patient access to innovative medicines underscores our commitment to advancing breakthroughs in biomedicine such as antibody drug conjugates, cell therapy, RNAi and more, Ed Zhang, company co-founder, chief operating and business officer, said in a statement.

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The Pharma Data

SEPTEMBER 16, 2020

New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Join this event on Roche’s LinkedIn page here. Roche highlights featured at ESMO Virtual Congress 2020.

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The Pharma Data

SEPTEMBER 19, 2020

The safety profile was consistent with the established profile of the individual drugs and no new safety concerns were identified. While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., pCR was observed in 57.6% (95% CI: 49.7–65.2)

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

HR 52

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Pfizer

NOVEMBER 23, 2022

(NYSE: PFE) today announced an agreement with the European Commission (EC) to supply its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to countries participating in the Joint Procurement Agreement across Europe. This agreement will supply participating countries up to 3.4

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The Pharma Data

APRIL 27, 2021

The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication. Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

APRIL 27, 2021

They are among the first products certified under the new European In Vitro Diagnostics Regulation (IVDR) and available as of today in countries accepting CE mark. About Elecsys ® NT- proBNP Tests for NT-proBNP, a cardiac hormone that is released into the blood when the heart wall is stretched, are developed and marketed by Roche.

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The Pharma Data

MAY 4, 2021

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).

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